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. 2015 Oct;8(5):615-8.
doi: 10.1111/cts.12298. Epub 2015 Jun 17.

Advancing a Vision for Regulatory Science Training

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Advancing a Vision for Regulatory Science Training

Joan E Adamo et al. Clin Transl Sci. 2015 Oct.

Abstract

Regulatory science, a complex field which draws on science, law, and policy, is a growing discipline in medical-related applications. Competencies help define both a discipline and the criteria to measure high-quality learning experiences. This paper identifies competencies for regulatory science, how they were developed, and broader recommendations to enhance education and training in this burgeoning field, including a multifaceted training approach.

Keywords: competencies; regulatory science; training; translational science.

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Figures

Figure 1
Figure 1
Core Thematic Areas. These 11 areas will help shape the training experiences of biomedical researchers pursuing regulatory science. The core thematic areas are based on a subset of the FDA's regulatory science priority areas and define the areas where focused skills, knowledge and abilities can be addressed by specific competencies.
Figure 2
Figure 2
Multipart Training. These represent several components to the education and training lifecycle which would benefit the Regulatory Science Practitioner.

References

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